Hypercapnic Respiratory FailureDISCONCT06367686
Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor
An observational study of Hypercapnic Respiratory Failure and Pulmonary Disease, Chronic Obstructive, run by The Hospital of Vestfold at 1 site in Norway.
Trial summary
The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hypercapnic Respiratory Failure, Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases
- What is being tested?
- IscAlert sensor
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- 30 Jan 2025to 16 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Adult, Older adult
Study population: Nine patients will be selected consequtive from the hypoventilation assessment planning program at the site. Additionally, two healthy individuals, who have no heart-, lung-, or circulatory diseases, no bleeding disorder, no sleep disorders, and no ties whatsoever to the sponsor (Sensocure AS), will be included as volunteers. Otherwise completely freely chosen by the investigators except they must not have any kind of (direct or indirect) acquaintanceship to the investigators. Eligible subjects will be invited to participate in this clinical investigation. All the subjects will be included at least one day before study procedure starts.
Who may be able to join
- The subject must meet all of the following inclusion criteria at the time of enrolment:
- EITHER
- Patient are at risk of hypoventilation and thus carbon dioxide retention.
- Either
- Under evaluation for treatment with non-invasive ventilation and maybe Long term oxygen treatment due to chronic obstructive pulmonary disease or
- Under evaluation for non-invasive ventilation support due to Obesity hypoventilation syndrome or due to a neuromuscular disorder.
Show all 11Show fewer
- OR
- Healthy volunteers
- ALL subjects:
- Subject must be 18 years or older
- Subject must be able to give written informed consent
Who cannot join
- Known allergy to local anesthetics.
- Participants should not have any kind of (direct or indirect) affiliation to Sensocure AS
- Healthy volunteers: No heart-, lung-, or circulatory diseases, no bleeding disorder, no sleep disorders
- Healthy volunteers should not have any kind of (direct or indirect) acquaintanceship to the investigators
- Active smoker/use of snuff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor; The DISCO-study
The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values.
Read the detailed description
he study is an open, prospective, single center clinical observational pilot investigation including 9 patients and 2 healthy volunteers. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa, with the transcutaneous carbon dioxide values measured at the forehead by a transcutaneous carbon dioxide-monitor, the arterial carbon dioxide measurements performed by blood gas analyses, and carbon dioxide measurements registered with the IscAlert sensor implanted in the muscle of the forearm. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values. The study will include patients with a tendency to hypoventilation, thereby giving rise to a carbon dioxide retention; 3 patients with chronic obstructive pulmonary disease with suspected hypercapnic respiratory failure who are evaluated for non-invasive mask-treatment and long-term oxygen treatment supply if needed. 3 patients with neuromuscular disorders and 3 patients with obesity hypoventilation syndrome who are evaluated for non-invasive mask treatment. The measurements will last for about 8 to 14 hours at night while the patients are sleeping. In addition, the study will also include 2 healthy volunteers as a control group. They will have the equipment mounted on them for about 8 hours during the day in connection with normal office work. Follow up by telephone 7 days +/-2 days after the measurements are finished. The inclusion period is expected to be about 9 months.
- Conditions
- Hypercapnic Respiratory Failure, Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases, Obesity Hypoventilation Syndrome (OHS)
- Being tested
- IscAlert sensor
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IscAlert sensorDevice
Insertion of an IscAlert sensor at the nasal mucosa
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease | 3 Chronic obstructive pulmonary disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night Receives: Device: IscAlert sensor | |
| Neuromuscular disease | 3 Neuromuscular disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night Receives: Device: IscAlert sensor | |
| Obesity hypoventilation syndrome | 3 Obesity hypoventilation syndrome patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night Receives: Device: IscAlert sensor | |
| Healthy volunteers | 2 healthy volunteers monitored with IscAlert sensor at nasal mucosa for approximately 8 hours during daytime Receives: Device: IscAlert sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure (level) of carbon dioxide at the nasal mucosa
Nasal mucosa's partial pressure of carbon dioxide (kPa) during insertion period
Measured: 14 hours
Secondary outcomes (5)
Bleeding
Amount of blood from insertion site (ml)
Measured: 7 days
Infection
Infection from insertion site at the discretion of the investigator (yes or no)
Measured: 7 days
Sinusitis
Developement of sinusitis at the discretion of the investigator (yes or no)
Measured: 7 days
Ulceration
Developement of ulceration at the nasal mucosa at the discretion of the investigator (yes or no)
Measured: 7 days
Pain at sensor insertion site
Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start30 Jan 2025
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Collaborators
- Sensocure AS
- Responsible party
- Principal investigator, Anne-Marie Gabrielsen, The Hospital of Vestfold
- Investigators
- Anne-Marie Gabrielsen, MD, PhD, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367686
- Sponsor's protocol ID
- REK KULMU B 714179
- Acronym
- DISCO
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD to other researchers